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BMS-986340

Phase 1

Cervical Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment1,109

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986340 · 1 trial · 11 indications

Phase 1 1
NCT04895709A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid TumorsCervical Cancer
RECRUITING1,109 Analytics
PHASE1RECRUITING
A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Cervical CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events (AEs)
Up to 120 weeks
Incidence of serious adverse events (SAEs)
Up to 120 weeks
Incidence of AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Up to either 21 or 28 days
Incidence of AEs leading to discontinuation
Up to 120 weeks
Number of deaths
Up to 120 weeks

Secondary Endpoints

Pharmacokinetic (PK) parameters of BMS-986340 administered as monotherapy: Maximum concentration (Cmax)
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Time to maximum concentration (Tmax)
Up to 120 weeks
PK parameters of BMS-986340 administered as monotherapy: Area under the concentration-time curve 1 dosing interval (AUC (TAU))
Up to 120 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1A: BMS-986340 Dose EscalationEXPERIMENTAL -
Part 2A: BMS-986340 Dose ExpansionEXPERIMENTAL -
Part 1B: BMS-986340 + Nivolumab Dose EscalationEXPERIMENTAL -
Part 2B: BMS-986340 + Nivolumab Dose ExpansionEXPERIMENTAL -
Part 1C: BMS-986340 + Docetaxel Dose EscalationEXPERIMENTAL -
Part 1A-J: BMS-986340 Dose EscalationEXPERIMENTAL -
Part 1B-J: BMS-986340 + Nivolumab Dose EscalationEXPERIMENTAL -
Part 2C: BMS-986340 + Docetaxel Dose ExpansionEXPERIMENTAL -
Part 2D: BMS-986340 + Pumitamig Dose ExpansionEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986340DRUGSpecified dose on specified days
BMS-936558-01DRUGSpecified dose on specified days
DocetaxelDRUGSpecified dose on specified days
PumitamigDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites47

Inclusion Criteria * Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are...

Countries:United StatesAustraliaCanadaGermanyIsraelItalyJapanSpain
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Competitive Landscape -Cervical Cancer 64 trials

Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT04895709lastUpdatePostDate: changed
LOWAug 17, 2026NCT04895709lastUpdatePostDate: changed
LOWJun 30, 2026NCT04895709lastUpdatePostDate: changed
LOWJun 30, 2026NCT04895709lastUpdatePostDate: changed
LOWJun 30, 2026NCT04895709lastUpdatePostDate: changed

Frequently asked questions about BMS-986340

What is BMS-986340 used for?

BMS-986340 is an investigational small molecule being developed for the treatment of cervical cancer. It is also being studied in other advanced solid tumors, including gastric cancer, colorectal cancer, non-small-cell lung cancer, head and neck cancer, renal cell carcinoma, urothelial carcinoma, pancreatic cancer, melanoma, ovarian cancer, and triple-negative breast cancer.

Who makes BMS-986340?

BMS-986340 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug as a monotherapy and in combination with other treatments for advanced solid tumors.

What phase is BMS-986340 in?

BMS-986340 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy in patients with advanced solid tumors.

What clinical trials is BMS-986340 in?

BMS-986340 is being studied in one active Phase 1 clinical trial with the identifier NCT04895709. This trial is recruiting participants with advanced solid tumors, including cervical cancer, and is evaluating the drug as a monotherapy and in combination therapy. The trial is enrolling up to 1,109 participants across multiple countries.

Is BMS-986340 the same as any other drug?

No alternative names for BMS-986340 have been reported. The drug is identified by its code name BMS-986340 in clinical trials and scientific literature. It is a distinct investigational compound being developed by Bristol-Myers Squibb for oncology indications.